Cardiometabolic Screening Program

Browse trials for

• Breast Neoplasms 12,544

Keywords

• Survivor

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 450 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is the lead sponsor of 572 studies on the registry; 73 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 67 (60%) have results posted.

Study arms

• Other
  Early stage breast cancer survivors

  Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins

  Other: Prescreening · Other: Screening and Enrollment · Behavioral: Baseline · Behavioral: Interpret BMI · Other: Interpret HbA1c · Other: Interpret lipid panel and assess other risk factors · Behavioral: Assess 10 year risk of cardiovascular event · Behavioral: Recommendations · Behavioral: Follow-Up

Interventions

• OtherPrescreening

  Eligible patients (history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins, reads and speaks English) complete survey for demographics, smoking status \& questions about cardiovascular disease.

• OtherScreening and Enrollment

  Consent

• BehavioralBaseline

  Behavioral Battery and Patient Reported Outcome Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-BR23) Labs (Hba1c + lipid panel if not done within 12 months or if abnormal within 1 year) Abstract vitals from chart review

  Also known as: Patient- reported outcomes questionnaires, labs, vitals results

• BehavioralInterpret BMI

  Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention

• OtherInterpret HbA1c

  HbA1c results categorized as follows: HbA1c \<5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication

• OtherInterpret lipid panel and assess other risk factors

  Based on above categories: HbA1c \<5.7%: Any of these cardiovascular disease risk factors: current/former tobacco use, total cholesterol \>200, family history of Coronary Artery Disease/Heart Attack in first degree family \<55 year old male or \<65 year old female, systolic blood pressure \>130 HbA1c 5.7-6.4%: Refer to Primary Care Provider and consider Healthful Eating, Activity and Weight Program (HEAWP) HbA1c 6.5%+: Refer to Endocrinology if HbA1c ≥8% Known diabetic on medication: Refer to Endocrinology if HbA1c ≥7%

• BehavioralAssess 10 year risk of cardiovascular event

  If risk factors are present - refer to Cardiovascular Disease Prevention Program

• BehavioralRecommendations

  Provide individual patient handout based on all above interventions

• BehavioralFollow-Up

  6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires

Primary outcomes

1. Prevalence of prediabetes

   The proportion of women with early stage breast cancer who have prediabetes: The number is determined through medical history, laboratory results, and baseline survey. Prevalence of prediabetes, will be estimated with an exact 95% confidence interval.

   Time frame: 3 years

2. Prevalence of diabetes

   The proportion of women with early stage breast cancer who have diabetes: The number is determined through medical history, laboratory results, and baseline survey. Prevalence of diabetes, will be estimated with an exact 95% confidence interval.

   Time frame: 3 years

3. Prevalence of hyperlipidemia

   The proportion of women with early stage breast cancer with hyperlipidemia as determined by medical history and laboratory results. Prevalence of hyperlipidemia will be estimated with an exact 95% confidence interval.

   Time frame: 3 years

4. Change in HbA1c

   The percent change in HbA1c laboratory results, at 6 and 12 months compared to baseline.

   Time frame: Baseline, 6 months, 12 months

5. Change in LDL cholesterol

   The percent change in LDL cholesterol (mg/dL) laboratory results at 6 and 12 months compared to baseline.

   Time frame: Baseline, 6 months, 12 months

6. Prevalence of obesity/ overweight

   The proportion of women with early stage breast cancer with BMI \>/= 25kg/mg squared. Body Mass Index (BMI) as recorded in participant electronic medical record will be evaluated to determine the percent change in Body Mass Index from baseline at 6 and 12 months.

   Time frame: Baseline, 6 months, 12 months

7. Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30

   Participants will complete the Quality of Life Questionnaire C30 The Quality of Life Questionnaire-C30, which includes 30 items. The 30 items assess physical, role, emotional, cognitive and social functioning, global health status or Quality Of Life scales, fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. The Quality of Life Questionnaire-C30 is scored on the basis of classical test theory (CTT), and uses the total item score as the scale score. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient). The percent change in Patient Reported Outcome scores from baseline is accessed at 6 months and 12 months.

   Time frame: Baseline, 6 months, 12 months

8. Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23

   Participants to complete the EORTC Quality of Life Questionnaire-BR23. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-BR23 has demonstrated validity and reliability as a quality of life questionnaires specific for breast cancer. The EORTC QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss. The scoring approach for the QLQ-BR23 is identical to QLQ-C30. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state). The percent change in scores from baseline is assessed at 6 months and 12 months.

   Time frame: Baseline, 6 months, 12 months

Secondary outcomes

1. Cardiovascular risk factors (tobacco use)

   The cardiovascular risk factor of tobacco use will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factor will be summarized descriptively.

   Time frame: 3 years

2. Cardiovascular risk factors (family history)

   The cardiovascular risk factor of family history will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factor will be summarized descriptively.

   Time frame: 3 years

3. Cardiovascular risk factors (hypertension)

   The cardiovascular risk factor of hypertension will be identified from review of medical history in electronic medical records, and surveys from participants. The proportion of patients enrolled in the study with this risk factors will be summarized descriptively.

   Time frame: 3 years

4. Referrals for individuals with pre-diabetes

   Total number of individuals with (prediabetes) referred to established institutional programs and resources. The number of referrals overall, by disease type, and per patient will be summarized descriptively.

   Time frame: 3 years

5. Referrals for individuals with diabetes

   Total number of individuals with diabetes referred to established institutional programs and resources. The number of referrals overall, by disease type, and per patient will be summarized descriptively.

   Time frame: 3 years

6. Referrals for individuals with risk of cardiovascular disease

   Total number of individuals with risk factors for cardiovascular disease referred to established institutional programs and resources. The number of referrals by disease type, and per patient will be summarized descriptively.

   Time frame: 3 years

7. Prevalence of prediabetes in women with breast cancer versus healthy individuals

   Compare the prevalence of prediabetes in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of prediabetes to the observed number in The investigators' cohort, adjusting for age and race.

   Time frame: 3 years

8. Prevalence of diabetes in women with breast cancer versus healthy individuals

   Prevalence of of diabetes in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of diabetes to the observed number in The investigators' cohort, adjusting for age and race.

   Time frame: 3 years

9. Prevalence of hyperlipidemia in women with breast cancer versus healthy individuals

   Prevalence of hyperlipidemia in women with breast cancer versus healthy controls from a national database, controlling for age and other confounding factors. The investigators will obtain access to a national database that provides information on the incidence of prediabetes, diabetes, hyperlipidemia, and history of breast cancer. The investigators will compare the expected number of incident cases of hyperlipidemia to the observed number in The investigators cohort, adjusting for age and race.

   Time frame: 3 years

Individual participant data

Plan to share: No